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AzTrials

Percutaneous Coronary InterventionNEW-IVUSNCT04739657

Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System

An observational study of Percutaneous Coronary Intervention and Coronary Artery Disease, run by Insight Lifetech Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Insight Lifetech IVUS System and Boston Scientific IVUS System
Type of treatment
Medical device
How many people
130 participants
Where
5 sitesChina
Study dates
1 Mar 2021to 27 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease which needs the qualitative and quantitative assessment by IVUS mearsurement, for whom the IVUS guidance during pre- and post-PCI is required.

Who may be able to join

  • Age: 18 Years and older;
  • Understand and willing to sign the informed consent form;
  • Clinical evaluation shows that the coronary artery stent implantation and the intravascular ultrasound(IVUS) guidance is required.

Who cannot join

  • Unable to understand or unwilling to sign the informed consent form;
  • Clinically diagnosed with severe coronary artery spasms;
  • Contraindicated to percutaneous coronary intervention (PCI);
  • Presence of any other factor that the investigator deems is unsuitable for enrollment or completion of this study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The General Hospital of the People's Liberation Army

    Beijing

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Zhongda Hospital of Southeast University

    Nanjing

  • Shanghai Zhongshan Hospital

    Shanhai

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System: A Multi-center Prospective Control Study

Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology, providing quantitative and qualitative assessment of coronary arteries. Besides, IVUS has already an established role in guidance and optimization of percutaneous coronary intervention. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) results measured by the two different IVUS diagnostic systems.

Read the detailed description

Many studies have reported that IVUS is an accurate method for determining the size of the target vessel undergoing stent implantation , and the optimal stent deployment (complete stent expansion and apposition and lack of edge dissection or other complications after implantation). The novel 60 megahertz(60MHz) high-definition IVUS has evolved as a next-generation IVUS imaging technology to provide higher image resolution than conventional 40 megahertz(40MHz) IVUS but with sufficient imaging depth preserved for the assessment of the entire vessel wall structure.

Insight Lifetech IVUS system includes TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic console. It is a novel device with high speed, high resolution, and high image acquisition rate enabling high-speed pullback imaging up to 10mm/sec.

This study is a prospective, multi-center, randomized, single-blind, controlled study with the primary target of investigating the differences, if any, between IVUS measurement results by the Insight Lifetech IVUS system and Boston Scientific IVUS system, imaging catheter of which was available at 40MHz during the study. Other purposes included analyzing the feasibility of the Insight Lifetech IVUS system's high-speed pullback during the IVUS assessment. A total of 130 patients will be recruited from 5 centers in China.

Being tested
Insight Lifetech IVUS System, Boston Scientific IVUS System
Keywords
high-speed, high-resolution IVUS
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insight Lifetech IVUS SystemDevice

    Also called IVUS diagnostic system

    The Insight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVision IVUS diagnostic catheter and VivoHeart IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.

  • Boston Scientific IVUS SystemDevice

    Also called IVUS diagnostic system

    The Boston Scientific IVUS System is intended for the examination of coronary intravascular pathology only, including Opticross IVUS diagnostic catheter and iLAB IVUS diagnostic device. IVUS imaging is used in patients who will undergo percutaneous coronary intervention.

Study groups in NCT04739657
Study groupRoleWhat they receive
ParticipantsSubjects whose clinical conditions require stent implantation, and the interventional procedure of which needs the guidance of IVUS imaging.
Receives: Device: Insight Lifetech IVUS System; Device: Boston Scientific IVUS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Stent Area in square millimeter(MSA)

    Comparison between the MSA measured by the Insight Lifetech Intravascular Ultrasound Diagnositic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson correlation analysis.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

Secondary outcomes (9)

  1. Clear Stent Length in millimeter (CSL)

    Comparison between the CSL measured by the Insight Lifetech Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson analysis.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

  2. Minimal Lumen Area in square millimeter(MLA)

    Comparison between the MLA measured by the Insight Lifetech Intravascular Ultrasound Diagnostic System and Boston Scientific Intravascular Ultrasound Diagnostic System, including mean relative deviation, confidence interval and standard deviation, as assessed by Bland-Altman analysis and Pearson analysis.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

  3. The rate of detected stent malapposition, tissue prolapse and dissection

    Detection rate of poor adherence, tissue prolapse and intercalation, for each system individually, and comparison between the two systems.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

  4. Stability of system (questionnaire)

    Evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :

    1. the stability of IVUS examination ;
    2. the usability of system operation;
    3. the definition of images.

    For each system in 1., 2., and 3., only one of the following five ratings is given:

    • very stable/convenient/clear images;
    • stable/convenient/clear images, inspection was unaffected;
    • slightly unstable/inconvenient/unclear images, inspection was unaffected;
    • unstable/inconvenient/unclear images, inspection was affected; (in the order of 1./2./3.)
    • N/A. and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems.

    Measured: estimated 1week on average, by opeartor's rating on questionaire

  5. Maneuvering performance of catheter (questionnaire)

    Evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :

    1. the pushability
    2. the crossability
    3. the angiographic visibility

    For each system in 1., 2., and 3., only one of the following five ratings is given:

    • excellent pushability/lesion crossability/visibility;
    • pushing met slight resistance/crossed lesion smoothly/good visibility, inspection was unaffected;
    • pushing met obvious resistance/crossed lesion after attempts/mediocre visibility, inspection was unaffected;
    • too resistant to push/unable to cross lesion/very poor visibility, inspection was affected; (in the order of 1./2./3.)
    • N/A. and is counted as 1 point for that particular rating. The distribution of the points in rating and how many points each rating individually owns are compared between the systems.

    Measured: estimated 1week on average, by opeartor's rating on questionaire

  6. Device success rate

    Device success rate, defined as a valid IVUS image for each system, and comparison between the two systems.

    Measured: estimated 1day on average, by intraoperative monitoring

  7. Rate of device-related adverse effects

    Rate of device-related adverse effects, for each system individually, and comparison between the two systems.

    Measured: estimated 1day on average, by intraoperative monitoring

  8. Rate of thrombosis, diffuse lesion and re-stenosis as discerned by IVUS

    Rate of thrombosis, diffuse lesion and re-stenosis discerned by each system individually, and comparison between the two systems.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

  9. Rate of plaque rupture and plaque properties as discerned by IVUS

    Rates of plaque rupture, lipid-rich plaque, fibrous plaque and calcified plaque, discerned by each system individually, and comparison between the two systems.

    Measured: estimated 1 month on average, by a third-party corelab IVUS image post-analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start1 Mar 2021
  3. Primary completion27 Apr 2021
  4. Study completion27 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739657
Sponsor's protocol ID
CTP-02-001
Acronym
NEW-IVUS
Status last verified
May 2022
First submitted
21 Dec 2020
Last updated
11 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li C, Yang J, Wang X, et al. CLINICAL VALIDATION OF A NEW INTRAVASCULAR ULTRASOUND SYSTEM: A COMPARATIVE ANALYSIS ON LENGTH MEASUREMENTS. J Am Coll Cardiol. 2022 Mar, 79 (9_Supplement) 827.

Questions about this trial

What is this clinical trial studying?

An observational study of Percutaneous Coronary Intervention and Coronary Artery Disease, run by Insight Lifetech Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Stent Area in square millimeter(MSA) (time frame: estimated 1 month on average, by a third-party corelab IVUS image post-analysis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.

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